Regulatory professionals frequently work with their supply chain colleagues to ensure all relevant documentation is provided for the export of goods from the country of origin. However, there are little-known US regulatory requirements with potentially significant administrative and criminal consequences for violation, and many manufacturers may not be aware of them. The US Departments of Commerce, State and the Treasury publish lists of US and international individuals a...

Late last year, US officials announced what they said was a breakthrough for the US Food and Drug Administration's (FDA) efforts to ramp up its inspection presence in China-a region with increasing pharmaceutical exports to the US. Background Under the terms of the December 2013 agreement between White House and Chinese officials, China was set to allow a "substantial increase in the number of US food and drug inspectors stationed in China," according to a White House...

The Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) plans to investigate the US Food and Drug Administration's (FDA) track record of inspecting generic pharmaceutical manufacturers in the coming year, the group said. Background OIG is DHHS' investigative body, and serves to audit agency programs and make recommendations as to how they can improve. Often times their reports are also used by members of Congress to push for changes. O...

The US Food and Drug Administration (FDA) has for years struggled with an influx of generic drug applications to the Center for Drug Evaluation and Research (CDER), resulting in a massive backlog that is only just starting to clear thanks to an influx in new user fee funding. But more than just the influx of abbreviated new drug applications (ANDAs), FDA's review resources have been stretched by the fact that many generic drug manufacturers are located outside the US, m...

If you follow the US Food and Drug Administration's (FDA) Warning Letters with any regularity, you know that the agency has been keeping a tight eye on Indian pharmaceutical manufacturers. But under the terms of a recent agreement, Chinese companies might soon find themselves in similar circumstances. Background FDA has long been hamstrung in its ability to inspect foreign manufacturers of pharmaceutical products, and in particular generic pharmaceuticals and active pha...

The US Food and Drug Administration (FDA) is out with a new draft guidance for industry establishing a framework by which a pharmaceutical manufacturer may delay, deny, limit or refuse an inspection of a facility by FDA. Background The draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection , released 12 July 2013, comes almost exactly one year after the passage of the Food and Drug Administration Safety and Innov...

US regulators announced this week their intent to continue a program they say allows companies to invite pharmaceutical regulatory officials into their facilities to go on site tours to learn more about the pharmaceutical industry and the way it produces its products. Background: Site Tours Program The plan, known as the Regulatory Project Management Site Tours and Regulatory Interaction Program, or the Site Tours Program, has been in effect in various forms since 1999,...

A South Korean medical device company is at the receiving end of a particularly blunt warning letter in which US regulators accuse the company of fixing almost none of the problems they found during a 2010 inspection. The 26 November 2012 letter to Seoul-based Sometech Incorporated, manufacturer of medical imaging equipment and high-frequency surgical instruments, references an April 2012 inspection by the US Food and Drug Administration (FDA). During that inspectio...

Chinese over-the-counter (OTC) manufacturer Shanghai Huhui Daily Use Chemical Products Company ('Shanghai Huhui') has been blasted by US Food and Drug Administration (FDA) inspectors for allegedly interfering with an investigation of the facility by using white-out on regulatory documents, among other serious alleged violations. The alleged deficiencies are outlined in a 14 November 2012 warning letter to Shanghai Huhui, released to the public on 5 December 2012. In ...

Inspectors with the US Food and Drug Administration (FDA) have found microbial contamination, unevaluated adverse event reports, ongoing water leaks, contaminated hoods, multi-colored residues, insects and at least one bird in a compounding pharmacy owned by the same company now associated with a massive outbreak of fungal meningitis. The observations-made in a FDA Form 483 inspection report of compounder Ameridose's Westborough, MA facility-closely track a 483 release...

Chronic regulatory lapses at manufacturing facilities are exacerbating drug shortages and patient safety issues, claims a new report published in The New York Times . The report chronicles the huge number of issues-some of them particularly egregious-that have occurred in recent years at facilities responsible for manufacturing pharmaceutical products. The problem is especially prominent at facilities that manufacture sterile injectable drugs, which have experienced...

Taiwan is preparing to join the Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S) in 2013, vaulting ahead of several other Asian countries preparing to do the same, reports Taiwan Today . PIC/S is an informal arrangement between consenting health regulatory authorities to exchange information, and chiefly works to promote the quality of pharmaceutical products. The organization is made up of two distinct parts which are different in regard to the...